BEUDAMED
    FDA Recall Terminated

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    Recall: Z-2168-2021 · Initiated June 14, 2021

    Recall

    Recall Number
    Z-2168-2021
    Event Number
    88210
    Firm
    ROi CPS LLC
    FEI Number
    3014527682
    Product Code
    MLS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 14, 2021
    Terminated
    March 8, 2023
    Address
    3000 E Sawyer Rd, Republic, MO, 65738-2758

    Description

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    Reason

    Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

    Action

    The firm notified their consignee on 06/24/2021 by email. The notice provided updated product labeling with a cautionary statement to remind the user to "activate away from the user's face and away from the infant and others." The distributor was directed to notify their customer.

    Distribution

    Missouri

    Quantity

    688 units